BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    HARDYDISK CEFUROXIME, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126561·

    MICRUS MICROCOIL DELIVERY SYSTEM, MDS03

    FDA 510(k)
    FDA Class 2 ·Neurology

    EMBRYON GIFT TRANSFER CATHETERS/SETS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Span-America

    FDA UDI
    SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300265600000·ZIMMER O.R. DONUT 12/CS

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 13, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 8, 2011

    ACCU-CHEK INFORM BASE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·February 8, 2008

    Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 14, 2015

    Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

    Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018